Formulation Specialist

Job Summary

We are seeking a dynamic and experienced Formulation Scientist in  Product development technical  due  diligence of dossiers  of  multiple  dosage forms  for  India  Market. Expertise  in oral  solid  dosage forms  and  sound  knowledge  in  trouble  shooting  of  process scale up  challenges.  Collaborating across functions of Portfolio Marketing Medical  affairs and  External partners. 

Roles & Responsibilities

• You will be responsible to drive the new product launch. Create a comprehensive plan with clear objectives and targets for the technical diligence process fostering strong relationships with stakeholders through regular communication and trust-building. Encourage cross-functional collaboration manage risks adhere to regulatory standards and monitor progress closely to ensure timely delivery of the product and continuously improving the process.
• You will be responsible to coordinate with cross-functional teams for Technical Diligence discussions and closure activities including Pre Apex Apex
• Review product document evaluation /  support team in resolving the issues provide support to prepare and finalize the gap report Discuss the identified gaps during due diligence with partner and hand hold for gap closures coordinate with partner for batches execution for composition / process improvements as required Generation of required data at partner end or outside laboratories closure of action items

   

  In order to expedite product due diligence and sharing gap report with partners and on time gap closure for product clearance

• You will be responsible for providing immediate support on need basis for addressing the Organisation priorities such as Global Manufacturing Process Robustness/ Oncology Portfolio Support for India.
• You will be responsible for providing expert formulation knowledge considering the consumer insights product understandings in design and delivering the consumer delighted products with better business gross margins.
• You will be responsible for Regulatory and Compliance support and drafting technical justification responses to the Chemistry Manufacturing and Controls (CMC) sections of product development queries/deficiencies notified by regulatory agencies.
• You will be responsible for knowledge sharing and providing guidance including technical to team members to develop formulation capabilities within teams. 
• You will be responsible for conducting literature reviews and staying abreast of the latest developments in formulation science ensuring that the organisation remains at the forefront of innovation in drug delivery systems.
• You will be accountable for developing and maintaining Standard Operating Procedures (SOPs) for formulation processes ensuring consistency and quality across all product development activities.
• You will be tasked with participating in technology transfer activities facilitating smooth transitions from research and development to commercial manufacturing and providing technical support during scale-up processes.

Qualifications :

Educational qualification: in Pharmaceutical

Minimum work experience: 6-8 years of Experience

Skills & attributes: 
Technical Skills

• Experience in Formulations & Development Integrated Drug development
• Experience in the Product development process in Research & Development Regulatory & Compliance
• Understanding of Different Markets (India & Brazil) 
• Understanding of Regulatory & Compliance requirement across geography (For Global Products).
• Experience in Biopharmaceutics Pharmacokinetics and Documentation
• Understanding of Intellectual Property (IP) laws and patents.

Behavioral Skills

• Excellent communication and interpersonal skills.
• Effective planning and high level of performance orientation.
• Strong Strategic thinking ability analytical and problem-solving abilities.
• Good at networking well developed influencing & assertiveness skills 

Additional Information :

About the Department

Integrated Product Development Organisation                                         

We integrate our deep science capabilities and cutting-edge technology to develop innovative accessible and affordable therapies for patients worldwide. We are a science-driven innovation-focused pharmaceutical company committed to accelerating access to healthcare solutions to patients around the world. We have End to end capabilities in API Formulations Clinical Intellectual Property and Regulatory Affairs. We are serving 55 markets including USA Canada Europe China LATAM ASEAN and all Emerging Markets with innovative and generic products ranging from Active pharmaceutical ingredients (API) Oral formulations Parenteral (Injectables Opthalmics) & Other dosages
Our product development efforts drive a portfolio of more than 1000 products Enabled by our robust R&D team consisting of more 200 scientists and functional experts and more than 150 doctorates we have filed 1071 patents and also published over 1000 papers for peer review over the years.

Benefits Offered
At Dr. Reddys we actively help to catalyse your career growth and professional development through personalised learning programs.
The benefits you will enjoy at Dr. Reddys are on par with the best industry standards. They include among other things and other essential equipment joining & relocation support family support (Maternity & Paternity benefits) learning and development opportunities medical coverage for yourself and your family life coverage for yourself.

Our Work Culture
Ask any employee at Dr. Reddys why they come to work every day and theyll say because Good Health Cant Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations but as a means to help patients lead healthier lives and were always attuned to the new and the next to empower people to stay fit. And to do this we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system they can make magic.
For more details please visit our career website at

Remote Work :

No

Employment Type :

Full-time